The Pacific Northwest Evidence-based Practice Center, Department of Medical Informatics and Clinical Epidemiology, Oregon Health and Science University, 3181 SW Sam Jackson Park Road, Portland, OR, 97239, USA.
Department of Veterans Affairs, Health Services Research and Development, VA Portland Health Care System, 3710 SW U.S. Veterans Hospital Road, Portland, OR, 97239, USA.
Syst Rev. 2018 Oct 22;7(1):172. doi: 10.1186/s13643-018-0834-2.
Systematic reviews (SRs) depend on comprehensive searches for evidence to provide balanced, accurate results. Requesting published and unpublished studies from pharmaceutical manufacturers has been proposed as a method to engage industry stakeholders and potentially reduce reporting bias. The Drug Effectiveness Review Project (DERP) has been requesting such evidence since 2003; the purpose of this study was to retrospectively evaluate the type and impact of the evidence received.
Data from "dossiers" submitted by pharmaceutical manufacturers for a set of 40 SRs conducted for DERP from July 2006 to June 2015 were retrospectively evaluated. Characteristics of data submitted in dossiers, including numbers, types, and characteristics of studies submitted and then included in DERP SRs, were abstracted. Time trends, study quality, publication status, and whether the submission represented a unique study or supplemental data to a published study were assessed. The impact of this evidence on SR conclusions was assessed using dual review. Differences were resolved through a consensus.
Over 9 years, 160 dossiers were received, relating to 40 DERP SRs. Out of 7360 studies/datasets submitted, 2.2% (160) were included in a SR. The ratio of submitted-to-included increased over time. Most were unique studies (23% were supplemental data sets), and almost 42% of the studies were unpublished. The majority of the studies were rated fair quality, with 7.3% rated good and 14% rated poor quality by the original SR authors. Considering all literature search sources, 7.2% of all studies included in the 40 SRs came from a dossier, and 16% of dossier studies were included in a meta-analysis. The dossier studies resulted in changes to conclusions in 42% of the SRs. Out of 46 unpublished unique studies included in a SR, 25 (54%) influenced the conclusions in favor of the manufacturers drug, 8% favored a competitor drug, and 40% favored neither. In 92% of cases favoring the manufacturer's drug, the dossier study was the only evidence for that drug in a specific population or outcome.
In SRs conducted for DERP, few studies submitted by pharmaceutical manufacturers were ultimately included in a SR. The included data helped to reduce reporting and publication bias by filling important gaps and in some cases led to altered conclusions.
系统评价（SRs）依赖于全面的证据搜索，以提供平衡、准确的结果。向制药公司索取已发表和未发表的研究报告已被提议作为一种与行业利益相关者接触的方法，并可能减少报告偏倚。药物效果评估项目（DERP）自 2003 年以来一直在要求提供此类证据；本研究旨在回顾性评估收到证据的类型和影响。
对 2006 年 7 月至 2015 年 6 月期间为 DERP 进行的 40 项系统评价中，制药公司提交的“档案”中的数据进行了回顾性评估。从档案中提取提交的数据的特征，包括提交的研究数量、类型和特征，以及随后纳入 DERP SR 的研究数量。评估了时间趋势、研究质量、出版状况，以及提交的内容是否代表一项独特的研究或对已发表研究的补充数据。使用双重审查评估该证据对 SR 结论的影响。通过共识解决差异。
9 年来共收到 160 份档案，涉及 40 项 DERP SR。在提交的 7360 项研究/数据集中，2.2%（160 项）被纳入一项 SR。提交与纳入的比例随时间增加。大多数为独特研究（23%为补充数据集），近 42%的研究未发表。大多数研究的质量被评为中等，原始 SR 作者将 7.3%评为良好，14%评为较差。考虑到所有文献检索来源，40 项 SR 中纳入的所有研究中，有 7.2%来自档案，而 16%的档案研究被纳入荟萃分析。档案研究导致 42%的 SR 结论发生变化。在纳入 SR 的 46 项未发表的独特研究中，25 项（54%）支持制造商的药物，8%支持竞争药物，40%对两者都不支持。在 92%的情况下，支持制造商药物的研究是该药物在特定人群或结局中唯一的证据。
在为 DERP 进行的 SR 中，制药公司提交的研究很少最终被纳入 SR。纳入的数据通过填补重要空白，在某些情况下导致结论改变，有助于减少报告和出版偏倚。
